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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1985-03-11 to 1985-03-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Trioctylphosphine
EC Number:
225-234-2
EC Name:
Trioctylphosphine
Cas Number:
4731-53-7
Molecular formula:
C24H51P
IUPAC Name:
trioctylphosphane
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adults (5 males and 1 female)
- Housing:Individually housed
- Cage: suspended, stainless steel
- Diet (e.g. ad libitum): Lab rabbit chow HF (Purine #5326)
- Water (e.g. ad libitum): Automatic watering system Municipal water supply (Elizabeth town water Co)
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6 °C - 21.1 °C (60 - 70 °F)
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12h / 12h

IN-LIFE DATES: From: To: 1985-03-26 to 1985-03-29

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Clipped and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
Approximately 24h
Observation period:
72h
Number of animals:
6 (5 males and 1 female)
Details on study design:
TEST SITE
- Area of exposure: back (between scapular and lumbar region)
- % coverage: 2.54 cm² (1 x 1 inch)
- Type of wrap if used: Plastic sheeting was wrapped around the animal and secured with tape. Plastic sheeting was then wrapped around the animal and secured with tape to retard evaporation an keep the test substance in contact with the skin without undue pressure. Elizabethan collars were then placed on the animals to prevent disruption of the wrappings and ingestion of the test material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently wiped free of excess test material with a paper towel and water.
- Time after start of exposure: 24h

OBSERVATION TIME POINTS
30 minutes after removal of wrappings and 72h after initiation of the treatment

SCORING SYSTEM:
- Method of calculation:

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24/72h
Score:
6.3
Max. score:
8
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
3.7
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
2.8
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
2.1
Max. score:
4
Reversibility:
not specified

Any other information on results incl. tables

Individual dermal irritation scores – 24h and 72h

Time

Sites

Type

6443 M

6444 F

6469 M

6453 M

6445 M

6451 M

Mean score

24h

Right side

(non-abraded)

Erythema

4S

4S

4S

3

3

4S

3.7

Edema

3

3

3

2

3

3

2.8

Left side

(Abraded)

Erythema

4S

4S

4S

3

3

4S

3.7

Edema

3

4

3

2

2

3

2.8

72h

Right side

(non-abraded)

Erythema

4N

4N

4N

4N

4N

4N

4.0

Edema

2

2

2

2

2

2

2.0

Left side

(Abraded)

Erythema

4

4N

4N

4N

4N

4N

4.0

Edema

2

2

2

2

2

3

2.2

 

Total

25.2

 

PDII

6.3

 N : Necrosis

S : Superficial necrosis

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The substance was corrosive to the skin. At 24h, four of six animals had superficial necrosis with moderate or severe edema at both the intact and abraded sites and two had mederate to severe erythema and edema. By 72h, all six animal had necrosis et the intact and/or abraded sites.
The primary Iirritation Index is 6.3
Executive summary:

In an in vivo skin corrosion study on rabbits, 0.5 mL of trioctylphosphine was applied on intact or abraded skin of rabbit.

Observations at 24h and 72h after application showed edema, erythema and necrosis.

A PDII was calculated to be 6.3.

The substance was considered to be corrosive to the skin.

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